Applies to drospirenone: oral tablet.

Serious side effects of Drospirenone

Along with its needed effects, drospirenone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking drospirenone:

Less common

• Heavy non-menstrual vaginal bleeding

Incidence not known

• Absent, missed, or irregular menstrual periods
• confusion
• difficult breathing
• irregular heartbeat
• nausea
• nervousness
• numbness or tingling in the hands, feet, or lips
• stomach pain
• stopping of menstrual bleeding
• vomiting
• weakness or heaviness of the legs

Other side effects of Drospirenone

Some side effects of drospirenone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acne
• breast pain or tenderness
• cramps
• decreased interest in sexual intercourse
• headache
• heavy bleeding
• increased weight
• loss in sexual ability, desire, drive, or performance
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected

For Healthcare Professionals

Applies to drospirenone: oral tablet, oral tablet chewable.

General

The most commonly reported adverse reactions have included acne, abnormal uterine bleeding, headache, breast pain, increased weight, dysmenorrhea, nausea, vaginal hemorrhage, decreased libido, breast tenderness, and irregular menstruation.^[Ref]

Genitourinary

Very common (10% or more): Unscheduled bleeding in cycle 1 (64.4%); unscheduled bleeding in cycle 13 (40.3%)

Common (1% to 10%): Metrorrhagia, dysmenorrhea, vaginal hemorrhage, irregular menstruation

Frequency not reported: Amenorrhea

Metabolic

Common (1% to 10%): Increased weight

Frequency not reported: Hyperkalemia

Endocrine

Common (1% to 10%): Breast pain, breast tenderness

Psychiatric

Common (1% to 10%): Decreased libido

Nervous system

Common (1% to 10%): Headache

Dermatologic

Common (1% to 10%): Acne

Gastrointestinal

Common (1% to 10%): Nausea